Improving Adherence in Adolescents and Young Adultswith Bipolar Disorder

项目摘要 双相情感障碍（BD）最常见的发作是在青春期后期和成年早期。而 药物治疗对青少年和年轻人（AYA）的BD症状有效， 在超过65%的AYA中，与低恢复率，高复发率和5.2倍的复发率相关。 增加自杀风险。依从性差是BD患者AYA预后不良的一个关键但可改变的风险因素。 AYA是一个理想的BD亚组，可以靶向和测试依从性干预措施，因为增强的 在这一关键的发展时期坚持社会、教育和职业目标， 终身BD自我管理技能的基础。到目前为止，还没有专门针对 在BD的AYA中坚持。 本R34提案是为响应RFA-MH-18-706，治疗的初步有效性试验而编写的， 预防和服务干预将与BD一起修改和测试AYA，这是一种有效的定制依从性 研究团队为BD成人开发的增强（CAE）干预。CAE是一种简单实用的 依从性促进干预，这是高度普遍化的现实世界的临床设置。在成人中，CAE 比严格的BD特定教育控制更能显著提高依从性。调查队 位于两个学术医疗中心（凯斯西储大学/CWRU和安大略大学）。 辛辛那提/加州大学）由两个NIH资助的PI领导，优势互补。 拟议的三阶段项目将确定AYA的相关特征和CAE所需的改进 （第1阶段），并使用基于患者反馈的迭代改进来标准化干预（第2阶段）。 第一和第二阶段将在12个月内完成。在第3阶段（13-36个月），我们将测试 采用随机对照试验（RCT）评估适应方法的可行性、可接受性和初步疗效 高风险、高需求组的设计：16-21岁的BD患者，对处方BD的依从性较差 药物治疗总体假设是，粘附性差的AYA伴BD（CAE-AYA）的CAE与 与常规强化治疗（ETAU）相比，6个月随访时的依从性有所改善。主 结局将是片剂常规问卷（TRQ）和电子依从性较基线的变化 监测（SimpleMed盒）。次要结果将评估精神症状和健康的变化- 相关的生活质量。其他分析将检查BD AYA中依从性变化的假定机制 因为它与双相情感障碍相关，包括双相情感知识不足、与临床医生沟通不良， 家庭、不稳定的药物常规和物质使用/危险行为。如果证明有效，拟议的试验将 为严格的CAE-AYA疗效试验铺平道路。

PROJECT SUMMARY The most common onset of bipolar disorder (BD) is during late adolescence and early adulthood. While pharmacotherapy is effective for BD symptoms in adolescents and young adults (AYA), poor adherence occurs in more than 65% of AYAs and is associated with low rates of recovery, high rates of relapse and a 5.2 fold increase in suicide risk. Poor adherence is a critical yet modifiable risk factor of poor outcomes in AYAs with BD. AYAs are an ideal BD subgroup to target and test adherence interventions given the potential impact of enhanced adherence on social, educational and occupational goals during this critical developmental period which can lay the foundation for lifelong BD self-management skills. To date, there are no interventions that specifically target adherence in AYAs with BD. This R34 proposal, written in response to RFA-MH-18-706, Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions will modify and test in AYAs with BD, an effective customized adherence enhancement (CAE) intervention developed for adults with BD by the investigative team. CAE is a brief, practical adherence promotion intervention that is highly generalizable to real-word clinical settings. In adults, CAE improves adherence significantly more than a rigorous BD-specific educational control. The investigative team is based in two academic medical centers (Case Western Reserve University/CWRU and University of Cincinnati/UC) led by two NIH-funded PIs with complementary strengths. The proposed 3-phase project will identify relevant characteristics of AYAs and needed refinements to CAE (Phase 1) and standardize the intervention using iterative refinements based on patient feedback (Phase 2). Phases 1 and 2 will be completed over a 12-month time-period. In Phase 3 (months 13-36) we will test the feasibility, acceptability and preliminary efficacy of the adapted approach using a randomized controlled trial (RCT) design in a high-risk, high-need group: AYAs ages 16-21 with BD who are poorly adherent with prescribed BD medications. The overall hypothesis is that CAE for poorly adherent AYAs with BD (CAE-AYA) will be associated with improved adherence at 6-month follow-up compared to enhanced treatment as usual (ETAU). The primary outcome will be change from baseline in the Tablets Routine Questionnaire (TRQ) and electronic adherence monitoring (SimpleMed boxes). Secondary outcomes will evaluate change in psychiatric symptoms and health- related quality of life. Additional analysis will examine the posited mechanisms of adherence change in BD AYAs as it relates to the adherence barriers of inadequate bipolar knowledge, poor communication with clinicians and family, unstable medication routines and substance use/risky behaviors. If proven effective, the proposed trial will pave the way for a rigorous efficacy trial of CAE-AYA.